BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183497 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09966
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. HOWEVER, BASED ON INVESTIGATION INFORMATION, THE CAUSE WAS DETERMINED TO BE THE PATIENT DID NOT PROPERLY CONNECT (E.G. OVERTORQUED) THE DISPOSABLE SET AND A SOLUTION BAG. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THIS REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. A BATCH REVIEW WILL NOT BE CONDUCTED. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A LINE FROM A SOLUTION BAG CAME OFF DURING FILL 1 AND THE HOME PATIENT WANTED TO END THERAPY SO HE COULD START OVER. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE CONNECTION ISSUE WITH THE SOLUTION BAG. THE HP STATED HAD TIGHTENED THE CONNECTION TOO MUCH AND HE STRIPPED THE THREADS. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HOMECHOICE